Cardiac Assist, Inc recalls TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary e…
- Recall date
- March 6, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1951-2020
- FDA classification
- Class II
- Brand / firm
- Cardiac Assist, Inc
- Sold / distributed
- US Nationwide distributions.
Why it was recalled
Failure to prime due to an assembly error
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
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